Phase IIIb Study of 36-Week Refill Exchanges of Port Delivery System with Ranibizumab in nAMD

Overview

Sponsor-declared trial summary

Key facts

Sponsor

F. Hoffmann-La Roche AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

17 Oct 2025 → ongoing

Decision date (initial)

2025-08-27

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

F. Hoffmann-La Roche AG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Others

To evaluate the effectiveness of the Port Delivery System with ranibizumab (PDS) administered Q36W

Secondary objectives 5

1. To evaluate the effectiveness of PDS Q36W based on additional functional and anatomical outcomes
2. To evaluate the treatment and visit burden of PDS Q36W
3. To evaluate the PROs of PDS Q36W
4. The safety objective for this study is to evaluate the safety of PDS
5. The device safety objective for this study is to evaluate the device and procedure-related safety

Conditions and MedDRA coding

Neovascular Age-Related Macular Degeneration (nAMD)

Regulatory references

Plan to share IPD

No

IPD plan description

N/A

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Age ≥ 50 years at time of signing Informed Consent Form
2. Initial diagnosis of nAMD within 24 months prior to the screening visit (according to recruitment strategy, a minimum of 50% [~125] patients diagnosed within 9 months prior to screening will be enrolled
3. Demonstrated response to prior anti-vascular endothelial growth factor (VEGF) intravitreal (IVT) treatment since diagnosis
4. nAMD disease stability detected per optical coherence tomography (OCT) at time of enrollment, as assessed by the investigator and confirmed by the central reading center (CRC)
5. Best-Corrected Visual Acuity (BCVA) of 34 letters or better (20/200 or better approximate Snellen equivalent),using Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters (see the BCVA manual for additional details) at screening and enrollment visits
6. Availability of historical OCT image data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD

Exclusion criteria 6

1. History of vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD)
2. Prior pars plana vitrectomy surgery
3. Prior treatment with Visudyne® (verteporfin for injection), external-beam radiation therapy, or transpupillary thermotherapy
4. The presence of subfoveal fibrosis or subfoveal atrophy in the study eye
5. Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the superotemporal quadrant of the eye (e.g., scarring, thinning, mass) that may affect the implantation, subsequent tissue coverage, and refill-exchange procedure of the PDS implant
6. Previous intraocular device implantation (not including intraocular lens implants)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline best-corrected visual acuity (BCVA) score as measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters averaged over Weeks 68 and 72

Secondary endpoints 14

1. Change from baseline in BCVA score over time (up to and including Week 72)
2. Proportion of patients who lose ≤ 15, ≤ 10, ≤ 5, or gain ≥ 0 letters in BCVA score from baseline over time up to and including Week 72
3. Change from baseline in center point thickness (CPT) over time up to and including Week 72
4. Change from baseline in central subfield thickness (CST) over time up to and including Week 72
5. Proportion of participants who do not undergo supplemental treatment with IVT ranibizumab 0.5 mg before each refill-exchange procedure and overall up to and including Week 72
6. Number of supplemental treatments with IVT ranibizumab 0.5 mg patients received in each refill cycle and overall up to and including Week 72
7. Frequency of study visits in each refill cycle and overall up to and including Week 72
8. Proportion of patients who report preferring ranibizumab 100 mg/mL delivered via the PDS compared with IVT treatment, as measured by the PDS Patient Preference Questionnaire (PPPQ) at Weeks 24 and 72
9. Proportion of patients with bilateral disease who report preferring PDS compared with IVT treatment, as measured by the PPPQ at Weeks 24 and 72
10. Incidence and severity of ocular and systemic (non-ocular) adverse events
11. Incidence and severity of adverse events of special interest, including ocular adverse events of special interest
12. Incidence and severity of ocular adverse events of special interest during the postoperative period (≤ 37 days of initial implantation) and follow-up period ( > 37 days after implantation surgery)
13. Incidence and severity of adverse device effects with PDS
14. Incidence, and severity of anticipated serious adverse device effects with PDS

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

Sponsor organisation

F. Hoffmann-La Roche AG

Address

Grenzacherstrasse 124

City

Basel

Postcode

4058

Country

Switzerland

Scientific contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Public contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Third parties 17

Locations

9 EU/EEA countries · 47 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 151 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications